Trial | NCT00334425  Report issue

Title

The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.
The Effect of LH-Priming During Early Follicular Phase on Ovarian Response and Pregnancy Outcome in GnRHa Down-Regulated Women, Stimulated With Exogenous Gonadotrophins in IVF Treatment

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    150
To evaluate the effect of LH-activity supplementation during the early follicular phase in GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by comparing different combinations with HP-HMG and r-FSH.
Study Started
Apr 30
2006
Last Update
Jun 13
2006
Estimate

Drug MENOPUR; GONAL-F

Criteria 

Inclusion Criteria:

Females between the ages of 18- 38 years (both included) at the time of randomisation
Patients for whom treatment with gonadotrophins and GnRH agonist (long protocol) in IVF setting is considered appropriate according to the criteria of the participating centre
Infertility for at least 1 year before randomisation (except for tubal infertility)
A maximum of two previous consecutive unsuccessful IVF cycles (i.e. not resulting in an ongoing pregnancy
25- 34 days of menstruation cycle
Body mass index (BMI) < 29 kg/m2

Exclusion Criteria:

Any clinically significant systemic disease (e.g., insulin dependent diabetes)
Endocrine or metabolic abnormalities (pituitary, adrenal, thyroid, pancreas, liver, or kidney) which can compromise participation in the study
Any concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), prostaglandin inhibitors (NSAIDs, including aspirin) and psychotropic agents (phenothiazine's, major tranquillisers) at the time of study entry. Note: these medications are disallowed for the study duration.
Presence of clinically significant uterine fibroids
Undiagnosed vaginal bleeding
Tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
Pregnancy, lactation or contraindication to pregnancy - must be confirmed by negative urinary pregnancy test at randomisation
No Results Posted